Silent brain lesion monitoring after VARIPULSE pulsed field ablation for atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-arm observational study enrolls adults with paroxysmal or persistent atrial fibrillation who undergo left-atrial ablation using the VARIPULSE pulsed field ablation system. Participants will receive brain MRI (DWI and FLAIR sequences) within 1–3 days after the procedure to detect silent cerebral lesions, and they will complete neurological and cognitive tests to look for subtle functional changes. Lesion characteristics—number, size, location—and total lesion burden will be recorded and compared with historical data from radiofrequency and cryoballoon ablation. Routine clinical follow-up for AF management will continue per institutional standard of care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1\) Patients undergoing atrial fibrillation ablation using the Varipulse™ catheter

Exclusion Criteria:

1. Individuals under 19 years of age
2. Patients who undergo concomitant radiofrequency ablation of the left atrium during the procedure
3. Patients with a history of stroke or transient ischemic attack (TIA)
4. Patients who have previously undergone ablation or surgery for atrial fibrillation
5. Patients with intracardiac thrombus or embolic events within the past 90 days
6. Patients who have experienced cardiac surgery or acute coronary syndrome within the past 90 days
7. Patients with contraindications to oral anticoagulant therapy, or those who require temporary discontinuation of anticoagulation due to procedural complications (e.g., cardiac tamponade)
8. Patients with a left ventricular ejection fraction (LVEF) of less than 35%
9. Women who are currently pregnant or planning to become pregnant during the study period
10. Patients with a life expectancy of less than one year
11. Patients at increased risk during MRI scanning (e.g., those with pacemakers or other metallic implants affected by MRI, or those with severe claustrophobia)

Where it's running

• Seoul National Universtiy Hospital, Seoul
  Seoul, Jongro-ku, South Korea Recruiting

Study contacts

• Study coordinator: Eue-Keun Choi, MD, PhD
• Email: choiek417@gmail.com
• Phone: 82-2-2072-0688

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.